NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

It is just insane what Senti and Hyperopia (aka: nwbo trying to line up Eden with DCVax-l approval) are suggesting.

They ask you to believe:

1. At the same time NWBO knew it had not even selected the prototype for Eden,
2. They submitted a marketing approval (150 day) request for DCVax-l
3. That they only wanted to take 80 days for review prior to either an RFI or MHRA determination period.
4. But really, they planned on day 45, to spring a request to change the approval request to be based upon Eden manufacturing instead of artisan,
5. When Eden had “several” more months before gmp compliant units could be manufactured and “qualified” plus several more months before it could be validated and engineering runs could finally be submitted to regulators for yet more months of MHRA determination.
6. It would be absolutely inane to request a 150 day DCVax-l marketing approval process to be based on a manufacturing process you hadn’t even selected a prototype for, let alone only selecting which prototype at day 45 of the 80 day review period. Imo.


Instead, NWBO has been meticulously planning to start commercialization with the artisan manufacturing process that was ready and expanded to meet over 90 patients a month upon commercial approval of DCVax-l. After which, at some point when Eden passed muster, they could transition to Eden to meet a much larger market.

Duh.